ZO SKIN HEALTH POST PROCEDURE RECOVERY SYSTEM- aluminum acetate kit

ZO Skin Health Post Procedure Recovery System by

Drug Labeling and Warnings

ZO Skin Health Post Procedure Recovery System by is a Otc medication manufactured, distributed, or labeled by ZO Skin Health, Inc., Bentley Laboratories, LLC, PakLab. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredient	Purpose
* When combined together in water, these ingredients form the active ingredient aluminum acetate. See Directions
Aluminum Sulfate Tetradecahydrate, 2850 mg	Astringent*
Calcium Acetate Monohydrate, 2016 mg	Astringent*

Uses

• For temporary relief of minor skin irritations due to rashes caused by soaps, detergents, cosmetics, or jewelry.

Warnings

For external use only.

When using this product

• avoid contact with eyes. If contact occurs, rinse thoroughly with water.
• do not cover compress or wet dressing with plastic to prevent evaporation
• in some skin conditions, soaking too long may overdry

Stop use and ask a doctor if

• condition worsens or symptoms persist for more than 7 days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• dissolve 1 packet in 12 oz. of cool or warm water.
• stir until fully dissolved; do not strain or filter.

The resulting mixture contains 0.45% aluminum acetate and is ready for use.

For use as a compress or wet dressing:

• soak a clean, soft cloth in the solution
• apply cloth loosely to affected area for 15 to 30 minutes
• repeat as needed or as directed by a doctor
• discard solution after each use

Inactive Ingredients

Water, Dextrin, Avena Sativa (Oat) Kernel Protein, Glycine Soja (Soybean) Protein, Whey Protein, Potassium Sorbate, Chitosan.

Other Information

• Store at controlled room temperature: 15-30°C (59-86°F), away from direct sunlight.
• You may report a serious adverse reaction to: 5 Technology Dr. Irvine, CA 92618

SPL UNCLASSIFIED SECTION

Dist. by ZO Skin Health, Inc. Irvine, CA 92618

PRINCIPAL DISPLAY PANEL - Kit Carton

ZO® SKIN HEALTH
BY ZEIN OBAGI MD

POST PROCEDURE RECOVERY SYSTEM

NDC: 42851-193-06

POMATROL® Soothing Ointment 50 mL / 1.7 Fl. Oz.
HYDRATING CRÈME Net Wt.113 g / 4 Oz.
SURFATROL®Astringent Solution Powder 10 ea. Net Wt.6 g / 0.21 Oz.

US Patent No. 9,248,160

INGREDIENTS AND APPEARANCE

ZO SKIN HEALTH POST PROCEDURE RECOVERY SYSTEM 
aluminum acetate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42851-193

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-193-06	1 in 1 CARTON	01/31/2019

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	50 mL
Part 2	1 TUBE	113 g
Part 3	1 PACKET	6 g

Part 1 of 3

ZO SKIN HEALTH POMATROL SOOTHING 
cleansing (cold creams, cleansing lotions, liquids, and pads) ointment

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Water (UNII: 059QF0KO0R)
INGR	HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	Tribehenin (UNII: 8OC9U7TQZ0)
INGR	SUNFLOWER OIL (UNII: 3W1JG795YI)
INGR	Polyglyceryl-4 Isostearate (UNII: 820DPX33S7)
INGR	Triethylhexanoin (UNII: 7K3W1BIU6K)
INGR	POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
INGR	Phenoxyethanol (UNII: HIE492ZZ3T)
INGR	MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
INGR	Hexyl Laurate (UNII: 4CG9F9W01Q)
INGR	BROCCOLI (UNII: UOI4FT57BZ)
INGR	OATMEAL (UNII: 8PI54V663Y)
INGR	PANTHENOL TRIACETATE, (+)- (UNII: 1206E8961B)
INGR	Ethyl Linoleate (UNII: MJ2YTT4J8M)
INGR	Erythritol (UNII: RA96B954X6)
INGR	Chlorphenesin (UNII: I670DAL4SZ)
INGR	ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	Oleyl Alcohol (UNII: 172F2WN8DV)
INGR	Butylene Glycol (UNII: 3XUS85K0RA)
INGR	N-ACETYLTYROSINE (UNII: DA8G610ZO5)
INGR	Aminopropyl Dihydrogen Phosphate (UNII: D5J0Q2CM4V)
INGR	Proline (UNII: 9DLQ4CIU6V)
INGR	UBIDECARENONE (UNII: EJ27X76M46)
INGR	VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
INGR	Ascorbic Acid (UNII: PQ6CK8PD0R)
INGR	Tocopherol (UNII: R0ZB2556P8)
INGR	Adenosine Triphosphate (UNII: 8L70Q75FXE)
INGR	Disodium Acetyl Glucosamine Phosphate (UNII: SC89MF712W)
INGR	HYALURONATE SODIUM (UNII: YSE9PPT4TH)
INGR	Sodium Benzoate (UNII: OJ245FE5EU)
INGR	Potassium Sorbate (UNII: 1VPU26JZZ4)
INGR	POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O)
INGR	PEG-12 Glyceryl Laurate (UNII: J07WW42G15)
INGR	HOMARINE HYDROCHLORIDE (UNII: 8866LNG61N)
INGR	POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
INGR	EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
COSMETIC		01/31/2019

Part 2 of 3

ZO SKIN HEALTH HYDRATING CREME 
lotions, oils, powders, and creams lotion

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Water (UNII: 059QF0KO0R)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	Petrolatum (UNII: 4T6H12BN9U)
INGR	Distearyldimonium Chloride (UNII: OM9573ZX3X)
INGR	Isopropyl Palmitate (UNII: 8CRQ2TH63M)
INGR	CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
INGR	Cetyl Alcohol (UNII: 936JST6JCN)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	OATMEAL (UNII: 8PI54V663Y)
INGR	Ophiopogon Japonicus Root (UNII: 90PS6JV9GZ)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	Vitamin A Palmitate (UNII: 1D1K0N0VVC)
INGR	Ascorbic Acid (UNII: PQ6CK8PD0R)
INGR	Tetrapeptide-21 (UNII: 179JUC43HU)
INGR	MYRISTOYL PENTAPEPTIDE-4 (UNII: PMA59A699X)
INGR	POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
INGR	GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
INGR	Maltodextrin (UNII: 7CVR7L4A2D)
INGR	Benzalkonium Chloride (UNII: F5UM2KM3W7)
INGR	Butylene Glycol (UNII: 3XUS85K0RA)
INGR	Sodium Chloride (UNII: 451W47IQ8X)
INGR	Benzyl Alcohol (UNII: LKG8494WBH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
COSMETIC		01/31/2019

Part 3 of 3

ZO SKIN HEALTH SURFATROL ASTRINGENT SOLUTION 
aluminum acetate powder

Product Information
Item Code (Source)	NDC: 42851-088
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Aluminum Acetate (UNII: 80EHD8I43D) (ALUMINUM CATION - UNII:3XHB1D032B)	Aluminum Acetate	4866 mg  in 6 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
OAT (UNII: Z6J799EAJK)
SOY PROTEIN (UNII: R44IWB3RN5)
WHEY (UNII: 8617Z5FMF6)
Potassium Sorbate (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-088-06	6 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	01/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	01/31/2019

Labeler - ZO Skin Health, Inc. (826468527)

Establishment
Name	Address	ID/FEI	Business Operations
PakLab		790530976	LABEL(42851-193) , MANUFACTURE(42851-193) , PACK(42851-193)

Establishment
Name	Address	ID/FEI	Business Operations
Paramount		001321058	MANUFACTURE(42851-193) , PACK(42851-193)